FDA.reportPublic FDA data

NA

Primary DI
20887587044917
Brand
NA
Company
Synthes GmbH
Model
400.735
Catalog number
400735
Device description
1.5MM TI MF CORTEX SCREW SELF-TAPPING W/FLUTES 5MM
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZLSCREW, FIXATION, INTRAOSSEOUS
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZLScrew, Fixation, IntraosseousDental2
MQNExternal Mandibular Fixator And/Or DistractorDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980199000
K981275000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980199000SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSSynthes (Usa)1998-04-17DZL
K981275000SYNTHES (USA) RATCHETING DISTRACTORSynthes (Usa)1998-06-25MQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20887587044917PrimaryGS10
H9804007350SecondaryHIBCC0
80887587044919Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088758704491720887587044917
8088758704491980887587044919

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
5
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982363541NASD351.724SD3517242026-11-05
10886982278746NA60.133.023601330232026-11-03
10886982346421NA60.133.182601331822026-11-03
00810112592986TriLEAP04.901.022049010222024-02-22
00810112592993TriLEAP04.901.024049010242024-02-22
00810112593006TriLEAP04.901.026049010262024-02-22
00810112593013TriLEAP04.901.028049010282024-02-22
00810112593020TriLEAP04.901.030049010302024-02-22
00810112593037TriLEAP04.902.008049020082024-02-22
00810112593044TriLEAP04.902.009049020092024-02-22
00810112593051TriLEAP04.902.010049020102024-02-22
00810112593068TriLEAP04.902.011049020112024-02-22
00810112593075TriLEAP04.902.012049020122024-02-22
00810112593082TriLEAP04.902.013049020132024-02-22
00810112593099TriLEAP04.902.014049020142024-02-22
00810112593105TriLEAP04.902.015049020152024-02-22
00810112593112TriLEAP04.902.016049020162024-02-22
00810112593129TriLEAP04.902.018049020182024-02-22
00810112593136TriLEAP04.902.020049020202024-02-22
00810112593143TriLEAP04.902.022049020222024-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118154910LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
00888118154927LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
00888118154934LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
00888118154965LEVEL ONE CMF, STERILEKLS-Martin L.P.MQN2026-10-21
10888118154979LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
10888118154986LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
00817421023668X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023675X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023682X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023699X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023705X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023712X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023729X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023736X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023743X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023750X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023767X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023774X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023781X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023798X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00083208006159Tatum Surgical Bone Fixation ScrewSuncoast Dental, IncDZL2026-08-14
00083208006166Tatum Surgical Bone Fixation ScrewSuncoast Dental, IncDZL2026-08-14
00888118128638LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128645LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128652LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128669LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128676LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128683LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118112682LEVEL ONE CMFKLS-Martin L.P.MQN2018-01-26
00888118113399DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26